What side effects are associated with this type of intervention?

Common treatments for carcinoma, including those targeting EBV-related nasopharyngeal carcinoma like VK 2019, often result in side effects such as hematologic toxicities (neutropenia, anemia, thrombocytopenia), fatigue, nausea, vomiting, and neuropathy. Targeted therapies may also cause skin toxicities, diarrhea, and ocular side effects. Management of these side effects is crucial to ensure patients can continue their treatment.

What prior FDA approvals exist?

FDA approvals for the treatment of carcinoma, particularly those targeting viral-related cancers like EBV-related nasopharyngeal carcinoma, include various immunotherapies and targeted therapies. For instance, pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for head and neck cancers, including nasopharyngeal carcinoma. These drugs work by enhancing the immune system's ability to fight cancer cells. Additionally, cetuximab, an EGFR inhibitor, has been approved for head and neck squamous cell carcinoma. While these treatments are not specifically for EBV-related cancers, they represent the type of targeted and immunotherapy approaches being explored in clinical trials like VK 2019.

What other types of research exist?

Promising novel alternatives to VK 2019 for treating EBV-related nasopharyngeal carcinoma include: 1) ZD6474 (vandetanib), an inhibitor of VEGFR, EGFR, and RET receptor tyrosine kinase activity, which has shown safety and tolerability in patients with solid malignant tumors. 2) PTK787/ZK222584 (vatalanib), an orally active inhibitor of VEGFRs, evaluated in patients with refractory or relapsed diffuse large B-cell lymphoma. These agents target pathways relevant to tumor growth and angiogenesis, making them potential alternatives for carcinoma treatment.

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Small Molecule

VK-2019 for Nasopharyngeal Cancer

Phase 2

Recruiting

Led By A. Dimitrios Colevas

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Eastern Cooperative Oncology Group (ECOG) performance status 2 or less

Must not have

All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment

Concurrent treatment with systemic cancer-directed therapy including complementary, alternative, herbal, or nutritional supplement-based treatments whose purpose is for anti-cancer effect

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing VK 2019, a new cancer treatment, on patients with a specific type of throat cancer linked to the Epstein-Barr virus who have no other treatment options. The goal is to see if VK 2019 can effectively fight the cancer and to understand its safety and effects on patients.

Who is the study for?

Adults with EBV-positive nasopharyngeal cancer not eligible for standard treatments can join. They must have good kidney function, controlled protein in urine, agree to birth control use, and be generally well enough (ECOG ≤2). Prior treatments should be completed with recovered side effects (except stable chronic issues), and blood counts need to meet specific levels.

What is being tested?

The trial is testing VK-2019's effectiveness against EBV-related nasopharyngeal carcinoma when no other treatment options are available. It includes pharmacokinetic and pharmacodynamic studies to understand how the drug behaves in the body and its biological effects.

What are the potential side effects?

Specific side effects of VK-2019 aren't listed but may include typical reactions such as fatigue, nausea, liver enzyme changes, or allergic responses. Side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can do most of my daily activities on my own.

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I am not eligible for any other standard cancer treatments.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My nasopharyngeal cancer cannot be cured, has spread, and lacks standard treatment options.

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My lymphoma cannot be cured with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, confirmed by a test.

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I am not on any other cancer treatments or supplements aimed at fighting cancer.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Area under the plasma concentration versus time curve (AUC)

Overall survival

Peak Plasma Concentration (Cmax)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VK-2019_armExperimental Treatment1 Intervention

Dose escalation and expansion up to 31 additional patients at a maximum of 1800 mg twice daily. Cycles will be defined as 28 days of treatment, subjects will receive VK 2019 until progression or dose limiting toxicity, for up to 12 cycles.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for carcinoma, particularly those targeting specific molecular pathways or viral associations like VK 2019, include targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by blocking specific molecules involved in tumor growth and progression. Immunotherapies, including checkpoint inhibitors, enhance the body's immune response against cancer cells. These treatments are crucial for carcinoma patients as they offer more personalized and potentially more effective options with fewer side effects compared to traditional chemotherapy. By targeting specific mechanisms, these therapies can improve outcomes and quality of life for patients.

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